Product information

From Health Canada

The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Authorization By Interim Order Revoked

Current status date:

2024-06-21

Original market date: See footnote 1

2021-07-29

Product name:

CASIRIVIMAB AND IMDEVIMAB

Description:

SINGLE-USE VIALS

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02516705

Product Monograph/Veterinary Labelling:

Date: 2022-06-07 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

HOFFMANN-LA ROCHE LIMITED
7070 Mississauga Road
Mississauga
Ontario
Canada L5N 5M8

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

2

Schedule(s):

Prescription ,  Schedule D ,  COVID-19 - IO - Authorization

 

American Hospital Formulary Service (AHFS): See footnote 3

08:18.24 

Anatomical Therapeutic Chemical (ATC): See footnote 4

J06BD07 CASIRIVIMAB AND IMDEVIMAB

Active ingredient group (AIG) number:See footnote5

0262970001

List of active ingredient(s)
Active ingredient(s) Strength
CASIRIVIMAB 1332 MG / 11.1 ML
IMDEVIMAB 1332 MG / 11.1 ML

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Pharmacovigilance/Monitoring Activity
Registry
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